Update on NICE decision for continued access to SMA treatments risdiplam (Evrysdi) and nusinersen (Spinraza)

25 November 2025

The National Institute for Health and Care Excellence (NICE) is assessing whether two treatments for spinal muscular atrophy (SMA) should be made permanently and routinely available on the NHS in England. A decision hasn’t been made yet, as the committee has asked for more information to ensure all the benefits of the treatments are fully captured.

Risdiplam (Evrysdi) and nusinersen (Spinraza) have been available for people living with SMA through a managed access agreement. This is a temporary arrangement that allows access to treatments while more evidence is gathered.

The agreement is currently due to expire in September 2026, so a decision is now needed for the permanent, routine use on the NHS in England. The first committee meeting took place on 11 November. Both treatments are available in Scotland.

NICE committees are independent. They are made up of about 25 to 30 members, including health and care professionals and academic researchers. At this committee meeting members heard evidence from clinicians and patient groups, and the companies that make the treatments – Biogen and Roche.

We are pleased to report that throughout the six-hour meeting, the voices of the patients and clinical experts were very much listened to and highly valued.

The outcome

Following that long meeting, NICE has temporarily paused the review for risdiplam (Evrysdi) and nusinersen (Spinraza). 

• Why the pause? The committee made good progress on many issues, but they realised they need more information (called ‘additional analysis’) before they can make their final recommendations.
• What extra information is needed? The committee needs a better look at the money side of things (the ‘economic modelling’) in three main areas:
  1. How the treatments affect the quality of life of patients.
  2. How much healthcare (like hospital visits or equipment) patients need.
  3. How the treatments affect the quality of life of the carers.
• The goal: The reason they are asking for this extra information is to make sure their final financial review correctly includes all the benefits of the treatments described by people living with SMA and doctors. They felt the true benefits of the treatments have not been fully captured by the current data. 
• Why the pause is good news: This pause is a positive sign. It demonstrates that NICE is listening closely to the lived experience shared by us, the people living with SMA every day. The committee is doing all it can to ensure that the economic calculations properly account for all the benefits and gains of these treatments. In particular, those real-world improvements that might not have been fully measured or captured in the original clinical trials.
• Partner organisation commitment: We, as collaborative partner patient organisations will continue to work closely with NICE and with the pharmaceutical companies during this pause to help move the process forward.

Next steps and timeline

• Who Provides the Data? Since this analysis is very technical and based on the financial plans created by the drug companies, NICE has asked the companies to provide the new data.
• What Happens Next? Once the companies provide the new information and NICE has reviewed it, they will schedule a second public committee meeting to discuss it.
• Timeline: We don’t have a date yet, but the second discussion is expected to happen in early 2026. NICE will not release any draft recommendations until after that second meeting.

Webinar update and your questions

SMA UK and Treat SMA are planning to produce a webinar to update the SMA community in more detail about this appraisal process.

• Who will be there? Patient and clinical experts who were part of the committee meeting will be joined by a representative from NICE.
• Submit Your Questions: If you have any questions about the pause, the next steps, or the process, please submit them through the form here.

Access to treatment continues

Crucially, while this review is paused, access to risdiplam (Evrysdi) and nusinersen (Spinraza) will continue. This applies to everyone: people who are already on the treatments and those who are just starting them.